Status:
COMPLETED
Efficacy and Safety of Ranibizumab in Patients With Visual Impairment Due to Choroidal Neovascularization Secondary to Pathologic Myopia
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Pathological Myopia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study is designed to evaluate the efficacy and safety of two different dosing regimens of 0.5 mg ranibizumab given as intravitreal injection in comparison to verteporfin PDT in patients with visu...
Eligibility Criteria
Inclusion
- Visual impairment due to choroidal neovascularization (CNV) secondary to PM
- Best corrected visual acuity (BCVA) in the study eye \> 24 and \< 78 Early Treatment Diabetic Retinopathy Study (ETDRS) letters
- High myopia (\> -6D), anterior-posterior elongation \> 26 mm; posterior changes compatible with the pathologic myopia
- Either lesion types in the study eye: subfoveal, juxtafoveal, extrafoveal
Exclusion
- Patients with uncontrolled systemic or ocular diseases
- Blood pressure \> 150/90 mmHg
- History of pan-retinal, focal/grid laser photocoagulation or intraocular treatment with any anti-VEGF or vPDT in the study eye
- Intravitreal treatment with corticosteroids or intraocular surgery within last 3 months in the study eye
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
277 Patients enrolled
Trial Details
Trial ID
NCT01217944
Start Date
October 1 2010
End Date
August 1 2012
Last Update
February 10 2014
Active Locations (74)
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1
Novartis Investigative Site
Vienna, Austria, Austria, 1090
2
Novartis Investigative Site
Linz, Upper Austria, Austria, 4021
3
Novartis Investigative Site
Vancouver, British Columbia, Canada, V5Z 3N9
4
Novartis Investigative Site
Montreal, Quebec, Canada, H1T 2M4